None listed
Conditions
Brief summary
A critical factor in the regulation of energy balance is the control of energy intake. Long-term reduction in intake is likely to result in parallel reduction in body weight and adiposity. Long-term maintenance of such a regime however is notoriously difficult to achieve through conscious dieting. Increased consumption of high satiety foods may lead to the subconscious reduction in energy intake and loss of body weight in a large portion of the population unable to consciously restrict their intake to levels matching their expenditure. Whilst lipids are commonly associated with poor satiety and weight gain relative to other dietary macronutrients, specifically carbohydrate and protein, there is some evidence from investigations into both macro- and micro-lipid components of a hierarchy within the lipid group itself and that specific lipid groups or lipid components may provide useful tools through which higher satiety food products may be developed
Interventions
This is a randomised, cross-over study in lean male participants (Body Mass Index (BMI) 18-25kg/m2). This study is the third of three parts and will investigate the potential bioactive properties of orally administered dairy lipids on satiety, hunger, energy intake and circulating hormones and other factors associated with appetite regulation, as compared with the commercially available lipid emulsion.
Subjects will be requested to fast for 12 hours prior to the test day.
Participants will be
This is a randomised, cross-over study in lean male participants (Body Mass Index (BMI) 18-25kg/m2). This study is the third of three parts and will investigate the potential bioactive properties of orally administered dairy lipids on satiety, hunger, energy intake and circulating hormones and other factors associated with appetite regulation, as compared with the commercially available lipid emulsion. Subjects will be requested to fast for 12 hours prior to the test day. Participants will be randomized to receive each of 6 treatments (200g yoghurt) over the study period. A single treatment will be given on each study day. The treatments will be administered at the Human Nutrition Unit on the morning of the intervention at 08:30am. This study is assessing the response of circulating hormones and other factors associated with appetite regulation including glucose, insulin, lipids including cholesterol, triacylglycerol & free fatty acids (FFA), Cholecystokinin (CCK), leptin, ghrelin, adiponectin, Glucagon-like peptide-1 (GLP-1) and peptide YY (PYY). A cannula will be inserted in the participants arm upon arrival to the Human Nutrition Unit on the morning of the intervention (~08:00am). Specifically the trial will measure the participants’ thoughts of hunger and fullness throughout a single day, and measure food intake at an ad libitum buffet style lunch meal given 225 minutes after the treatment as well as the levels of circulating hormones and other factors associated with appetite regulation. Study visits to be separated by a wash-out period of at least 7 days. Treatments: The treatments described below are for delivery of a single bolus lipid emulsion ‘shot’ (10g) incorporated into a dairy-yoghurt (190g). The composition of the 6 shots are: A. Control lipid + phospholipid emulsion with fatty acid composition matched to Olibra B. Dairy lipid + phospholipid emulsion with fatty acid composition not matched to Olibra C. Non-emulsified control lipid + phospholipid with fatty acid composition matched to Olibra D. Non-emulsified dairy lipid + phospholipid with fatty acid composition not matched to Olibra E. Dairy lipid + soy lecithin emulsion with fatty acid composition not matched to Olibra F. OlibraTM emulsion The composition of the 760 kJ fixed load yoghurt that the shots will be mixed into: 5.7g fat, 28 en% fat 6.5g protein, 14 en% protein 27.4g Carbohydrate (CHO), 58 en% CHO Participants will be randomized to receive all 6 beverages detailed above over 6 study days. The treatments are matched for weight (200g) and macronutrient composition. Treatments A, C and F will have similar fatty acid composition (matched to that of Olibra – the commercially available lipid emulsion). Treatments B, D and E containing the dairy lipid will have a different fatty acid composition to treatments A, C and F. There must be at least 7 days between study visits in this study. Participants are free to choose which days they come in to the unit so the study duration will be from 6 weeks to a few months.
Sponsors
Lactopharma
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Men, aged 18-65y Lean (BMI: Caucasian/Indian/Asian 17.5-25 kg/m2; Pacific Peoples 18.5-26 kg/m2) Normal glucose control (<5.5 mmol/L); liver function; iron studies; lipids; Full blood count (FBC) No history of diabetes or heart disease; healthy, as ascertained by self-report Desire to participate in clinical trial
Exclusion criteria
Endocrine, cardiovascular, gastrointestinal (GI), metabolic disease or cancers, including history Weight change of >5 kg in the previous 6 months Medications that may affect weight/appetite Cigarette smoking within previous 6 months Unwilling unable to comply with protocol/participation in another clinical trial Any current diagnosis or history of significant disease
Outcome results
None listed